23.4% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution of sodium chloride in Water for Injection, USP. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program.

Each mL contains sodium chloride, 234 mg (4 mEq/mL). The solution contains no bacteriostat, antimicrobial agent or added buffer. The specific gravity is 1.15, and the osmolarity is 8.01 mOsmol/mL (calc.). The additive may contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 5.0 (4.5 to 7.0).

Sodium chloride is an electrolyte replenisher. Sodium is the principal cation of extracellular fluid. With a normal plasma concentration of 142 mEq/L, sodium comprises more than 90% of the total plasma cations. While sodium can diffuse across membranes, the intracellular sodium concentration is maintained at a much lower level than extracellular concentrations — the so-called “sodium pump.” Compensation for loss of intracellular potassium occurs through an increase in intracellular sodium. Sodium is the principal ion that determines osmotic pressure of interstitial fluids and the degree of tissue hydration.

Normal salt intake ranges from 5 g to 15 g/day, most of which is excreted by the kidneys. Control of water and salt excretion is very intricate, involving filtration by the glomerulus and reabsorption by the tubules of approximately 99% of the filtered load. The actual quantities excreted depend upon the requirements prevailing at the moment. Finer adjustments of the tubular absorptive mechanisms are influenced by osmotic interrelationships between cell water, plasma and urine, and by certain steroid hormones influencing electrolyte excretion and the posterior pituitary hormone regulating water excretion. When food intake ceases or salt is withheld, the urine content of sodium chloride diminishes rapidly so that body stores are conserved. Similar renal retention of electrolytes occurs when salt is lost via vomiting. However, in other conditions, the kidneys fail to eliminate sufficient sodium. Examples include congestive heart failure, cirrhosis, nephritis, or hypersecretion of the adrenal cortical hormones. The result is retention of both salt and water, producing an excessive accumulation of extracellular fluid, which may be effectively treated by restricting salt intake and use of a diuretic.

Symptoms of sodium chloride deficiency include nausea, vomiting, and increased muscle irritability manifested by cramps, and possibly convulsions. It is recognized that excessive sweating can cause “heat cramps” — muscle cramps in the abdomen and extremities, which can be relieved completely by ingestion of a weak salt solution. Other causes of salt depletion include overzealous treatment of fluid and sodium retention, diabetic acidosis, burns, excessive sweating with free drinking of water, repeated paracentesis for removal of ascitic fluid, adrenal cortical hypofunction and certain forms of nephritis, as well as abnormal loss of gastrointestinal secretions. Reduction in the osmotic pressure of extracellular fluid accompanies salt loss. Urine volume may be maintained, but urine is hypo-osmolar secondary to salt conservation by the renal tubules.

23.4% Sodium Chloride Injection, USP is indicated for use as an electrolyte replenisher in parenteral fluid therapy. It serves as an intravenous sodium supplement in hyponatremia or low salt syndrome, as an additive for total parenteral nutrition (TPN), and as an additive for carbohydrate-containing I.V. fluids.

Toxicity secondary to intestinal obstruction is usually accompanied by a marked reduction in serum chloride, and sodium chloride supplements can have a lifesaving effect. Symptoms of sodium chloride deficiency are very similar to those of Addison’s disease, and large doses of sodium chloride will produce temporary alleviation of symptoms. Other disorders where sodium chloride is of clinical benefit include extensive burns, failure of gastric secretion and postoperative intestinal paralysis.

23.4% Sodium Chloride Injection, USP is hypertonic and must be diluted prior to administration. Inadvertent direct injection or absorption of concentrated sodium chloride solution may give rise to sudden hypernatremia and such complications as cardiovascular shock, central nervous system disorders, extensive hemolysis, cortical necrosis of the kidneys and severe local tissue necrosis (if administered extravascularly).

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

In patients with diminished renal function, administration of solutions containing sodium may result in sodium retention. The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Excessive administration of potassium-free solutions may result in significant hypokalemia.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

General — Excessive amounts of sodium chloride by any route may cause hypokalemia and acidosis. Excessive amounts by the parenteral route may precipitate congestive heart failure and acute pulmonary edema, especially in patients with cardiovascular disease and in patients receiving corticosteroids or corticotropin or drugs that may give rise to sodium retention. Special caution should be used in administering sodium-containing solutions to patients with severe renal impairment, cirrhosis of the liver or other edematous or sodium-retaining states.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Do not use unless the solution is clear and seal is intact.

Pregnancy Category C — Animal reproduction studies have not been conducted with 23.4% Sodium Chloride Injection, USP. It is also not known whether sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers — It is not known whether 23.4% Sodium Chloride Injection, USP is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sodium chloride is administered to a nursing woman.

Pediatric Use — Safety and effectiveness of 23.4% Sodium Chloride Injection, USP have not been established in pediatric patients. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

Excessive administration of 23.4% Sodium Chloride Injection, USP may result in electrolyte imbalance with water retention, edema, loss of potassium and aggravation of an existing acidosis.

Excessive sodium chloride intake is accompanied by excretion of crystalloids, in an attempt to maintain normal osmotic pressure. Increased excretion of potassium and bicarbonate can result in acidosis. There is also a rapid elimination of any foreign salt, such as iodide and bromide, being used therapeutically.

23.4% Sodium Chloride Injection, USP is administered intravenously, but only after dilution in a larger volume of fluid. Maintenance electrolyte solutions usually contain sodium at a concentration of 33 to 40 mEq/L, on the assumption the patient will receive two to three liters of fluid/day. A typical oral salt intake of 10 g/day is equivalent to 171 mEq/day. But intake can range from 5 to 15 g sodium chloride/day, and patients on a sodium-restricted diet may receive 1 to 2 g of sodium/day. The actual dose of sodium chloride administered depends upon specific patient requirements, which are usually determined by review of serial blood samples and clinical evaluation. In solutions for total parenteral nutrition (TPN), adults typically receive 120 mEq of sodium/day (range: 75-180 mEq/day), whereas preterm infants receive 3-4 mEq/kg/day.

Drug Interactions

Additives may be incompatible with the fluid dispensed from this container. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique, mix thoroughly and do not store.

Recommended Directions for Use of the Pharmacy Bulk Package

Use Aseptic Technique

Perform all manipulations in an appropriate laminar flow hood.

Aseptically remove aluminum overseal.

Insert piercing pin of sterile transfer set and suspend unit in a laminar flow hood. Insertion of a piercing pin into the outlet port should be performed only once in a Pharmacy Bulk Package solution. ONCE THE OUTLET SITE HAS BEEN ENTERED, THE WITHDRAWAL OF CONTAINER CONTENTS SHOULD BE COMPLETED PROMPTLY IN ONE CONTINUOUS OPERATION. Should this not be possible, a maximum time of 4 hours from transfer set pin or implement insertion is permitted to complete fluid transfer operations, i.e., discard container no later than 4 hours after initial closure puncture.

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